Recent FDA approval may be promising for lung cancer patients

A previous blog post discussed an ongoing trial (Keynote-028) of a promising new treatment for mesothelioma. The study aimed to examine the effects of Keytruda, a checkpoint inhibitor immunotherapy drug, on patients with mesothelioma. The U.S. Food and Drug Administration has now approved Keytruda for treatment of advanced or metastatic urothelial carcinoma, bringing it one step closer to becoming an approved treatment option for those with mesothelioma.

The Keynote-045 study aimed to test the effects of Keytruda on patients with advanced or metastatic urothelial carcinoma, also called transitional cell carcinoma. This is a type of cancer most commonly affecting the urinary system. It is important to note that the inhalation or consumption of liquids containing asbestos may enter the urinary system. Even asbestos in the lungs can eventually pass into the blood stream, working its way toward the kidneys, which are connected to the bladder.

The study measured participants’ combined positive score, a formula that takes into account patients’ percentage of positive tumor cells in relation to infiltrating immune cells. Those with a combined positive score of at least 10 percent showed a 43 percent reduction in risk of death with Keytruda as compared to the risk of death with chemotherapy.

In patients whose urothelial carcinoma continued to progress despite chemotherapy, Keytruda reduced the risk of death by 27 percent. Patients who received Keytruda had a median overall survival rate of over 10 months as compared to those who did not receive Keytruda, who had a median overall survival rate of just over seven months.

The results of the Keynote-028 study were at least as promising as the results of the Keynote-045 study. Keynote-028 revealed that the overall survival rate for advanced mesothelioma patients on Keytruda was 18 months as compared to advanced mesothelioma patients not on Keytruda, whose overall survival rate was six to seven months.

It remains to be seen if the FDA will extend its approval of Keytruda to those suffering from mesothelioma. Considering that currently, the only approved treatment for pleural mesothelioma is chemotherapy, this second-line treatment — if approved — may provide previously unattainable increased longevity for patients with mesothelioma.

Source:, “FDA Approves Keytruda Approved for Urothelial Carcinoma“, Jason M. Broderick, May 18, 2017